DIET & NUTRITION 
PATIENT EDUCATION 
OBESITY/WEIGHT MANAGEMENT 
EXERCISE/TRAINING 
LEGAL MATTERS 
GUIDELINES/RECOMMENDATIONS The SunRISe-2 phase 3 trial was stopped early for futility after gemcitabine intravesical system plus cetrelimab failed to outperform chemoradiotherapy in MIBC patients ineligible for or declining radical cystectomy. 24-month BI-EFS favored CRT (66.5% vs 58.5%), and 12-month OS rates were 95.4% versus 88.8%, reinforcing the durability of standard treatment.
Clinical Considerations
- Gem-iDRS + CET showed inferior BI-EFS versus CRT (HR 1.71; 95% CI 1.16-2.53), with CRT also leading on 12-month OS (95.4% vs 88.8%)
- Complete responders at week 18 fared similarly across arms (76.2% vs 72.0% 24-month BI-EFS), suggesting response depth may matter more than modality
- Treatment discontinuation was higher in the investigational arm (15.0% vs 9.5%), despite comparable grade 3+ TRAE rates (26.8% vs 32.0%)
- No treatment-related deaths occurred with Gem-iDRS + CET; one occurred in the CRT arm
Practice Applications
- Maintain chemoradiotherapy as the bladder-preservation standard for RC-ineligible MIBC patients
- Counsel patients that investigational intravesical approaches remain unproven against established CRT
- Monitor week 18 response closely as a prognostic checkpoint regardless of treatment arm
- Follow updated MFS and OS data as median times were not yet reached in either arm
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